Events

Retiro De Equipo (Recall) de Device Recall Zimmer M/L Taper Hip Stem Standard & Extended Offset

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Zimmer, Inc..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    68390
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2033-2014
  • Fecha de inicio del evento
    2014-05-23
  • Fecha de publicación del evento
    2014-07-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-03-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127544
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
  • Causa
    Black residue observed in the sterile pouch of the m/l taper and kinectiv stems.
  • Acción
    Zimmer sent an Medical Device Recall Letter on June 4, 2014, to their Distributors. On June 9, 2014, Zimmer sent Medical Device Recall Letters to the physicians. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed: 1. Locate all products from the affected lots and quarantine them immediately, if not previously done so per the May 23, 2014 Notice of Suspension of Loaner Pool. 2. Confirm the physical count of all affected product in loaner pool in your territory and complete the Confirmation of Loaner Pool Inventory and Return Certification Form (Attachment 2), and email a completed copy of Attachment 2 to corporatequality.postmarket@zimmer.com. 3. Return the recalled product along with the completed Confirmation of Loaner Pool Inventory and Return Certification Form (Attachment 2). 4. Identify additional customers that may have used this product in the past 12 months by completing the spreadsheet template provided to you via email or confirm that Zimmer has identified all current customers in your territory. 5. If after reviewing this notification you have further questions or concerns please call the customer call center at 1-877-946-2761 between 8:00 am and 5:00pm EST.

Device

Device Recall Zimmer M/L Taper Hip Stem Standard & Extended Offset
  • Modelo / Serial
    Product ID: 00771100500, Lot #: 60418073, 60814878, 61085493, 61221743, 61576204, 61621459, 61621460, 61801966, 61825644, 61825646, 61851938, 61856660, 61899990, 61909935, 61957246, 61963045, 61967714, 61978787, 62004470, 62071524, 62078280, 62101467, 62143024, 62145543, 62145545, 62179230, 62201751, 62207880, 62213705, 62219904, 62243355, 62309446, 62316375, 62323504, 62329221, 62329222, 62367889, 62386075, 62450636, 62458975, 62472170, 62547040, 62554175, 62564731, 62564732, 62571806, 62615699, 62645213, 62645214, 62652987, 62667687, 77000640 & 77002057.  Product ID: 00771100520, Lot #: 7886860, 60371589, 60389984, 60911201, 60993979, 60999893, 61112021, 61585384, 61622518, 61825666, 61825667, 61851924, 61904650, 61951060, 61967705, 62004472, 62004473, 62028785, 62107673, 62130149, 62135097, 62253657, 62253658, 62323506, 62335517, 62410994, 62458977, 62459364, 62472174, 62503201, 62547042, 62564734, 62571808, 62615703, 62636751 & 62636752.  Product ID: 00771100600, Lot #: 61067223, 61389192, 61440890, 61613526, 61699183, 61765877, 61772616, 61851919, 61870556, 61919457, 61925455, 61925460, 61978791, 61985997, 61998399, 62004516, 62016452, 62044968, 62125014, 62125015, 62125017, 62145557, 62184296, 62187413, 62213709, 62213710, 62219910, 62219911, 62226002, 62236538, 62323511, 62329225, 62329226, 62380990, 62416655, 62433042, 62459366, 62466091, 62489957, 62489958, 62529364, 62547046, 62554183, 62590697, 62615709, 62645219, 62652995, 62659348 & 77002100.  Product ID: 00771100620, Lot #: 7887710, 11006337, 60814885, 60837122, 60876619, 60935819, 61112024, 61304434, 61755954, 61784588, 61904652, 61945405, 61972436, 61998401, 62014575, 62016455, 62130154, 62153643, 62158627, 62201765, 62226004, 62249176, 62253663, 62274955, 62335527, 62356442, 62361541, 62361542, 62416667, 62423066, 62466094, 62489397, 62509251, 62540605, 62564743, 62571809, 62577958, 62586851, 62622688, 62622689 & 62653004.  Product ID: 00771100700, Lot #: 61734759, 61837544, 61978805, 62023873, 62059128, 62059132, 62078290, 62096904, 62101438, 62163749, 62169669, 62184307, 62184309, 62201774, 62201775, 62213721, 62226013, 62253668, 62253669, 62282222, 62295527, 62295529, 62302348, 62309461, 62316392, 62316393, 62316394, 62343052, 62350640, 62370012, 62379099, 62380993, 62380998, 62393286, 62393287, 62400751, 62433056, 62478042, 62478043, 62483286, 62484613, 62488308, 62488310, 62488314, 62521917, 62529381, 62540611, 62564748, 62586859, 62608633, 62615717, 62615720, 62630027, 62645229, 62645233, 62653011, 62653012, 62653018 & 62659363.  Product ID: 00771100720, Lot #: 60718307, 61329143, 61721071, 61791501, 61904659, 61915121, 61963043, 61978809, 61978811, 61998380, 62004524, 62053392, 62089239, 62089240, 62118159, 62150305, 62163761, 62198235, 62226017, 62231904, 62249178, 62271083, 62282231, 62289028, 62309538, 62316415, 62343058, 62445432, 62540618, 62548498, 62554198, 62571815, 62577960, 62577961, 62601229, 62608641, 62630036 & 62637054. Product ID: 00771100900, Lot #: 61239370, 61690526, 61874323, 61915128, 62004528, 62067023, 62089044, 62089241, 62107690, 62130175, 62135117, 62155221, 62184318, 62198246, 62207908, 62213747, 62213749, 62226020, 62226029, 62243384, 62258677, 62316423, 62323533, 62329246, 62329250, 62329251, 62329252, 62335549, 62350650, 62356461, 62361555, 62370030, 62370033, 62381019, 62386089, 62393301, 62393303, 62438941, 62444848, 62450646, 62452759, 62466109, 62478016, 62488334, 62488335, 62488336, 62489407, 62489414, 62489418, 62521935, 62529418, 62537946, 62547023, 62547026, 62550180, 62560190, 62568620, 62571824, 62571825, 62577965, 62577967, 62577978, 62577980, 62586867, 62590715, 62601238, 62608649, 62608653, 62630041, 62630044, 62636780, 62636785, 62653032, 62653040, 62665781, 62665786, 62665789 & 62667721. Product ID: 00771100920, Lot #: 61253985, 61375619, 61512772, 61585393, 61595710, 61957210, 61998409, 62041869, 62053407, 62067029, 62067030, 62078314, 62096919, 62114320, 62213762, 62226037, 62238364, 62243395, 62243396, 62243397, 62271102, 62309568, 62309570, 62309571, 62323544, 62343077, 62350658, 62356469, 62405422, 62478080, 62509279, 62515355, 62548501, 62550192, 62554218, 62571835, 62594217, 62601245, 62601246, 62608668, 62615738& 62636797. Product ID: 00771101000, Lot #: 61104476, 61365526, 61601704, 61904677, 62041873, 62101423, 62135135, 62141463, 62153669, 62163774, 62179304, 62191529, 62201817, 62213771, 62213774, 62219942, 62243404, 62323548, 62323553, 62323554, 62329274, 62335561, 62342732, 62343085, 62356476, 62356477, 62361572, 62370053, 62370054, 62381042, 62390757, 62405427, 62423111, 62433081, 62438955, 62438956, 62438959, 62452774, 62459016, 62459390, 62465786, 62466117, 62472217, 62484353, 62488357, 62488361, 62488362, 62489436, 62515359, 62515360, 62515361, 62521950, 62540635, 62540637, 62547083, 62550193, 62554223, 62554224, 62554227, 62554229, 62560013, 62564777, 62571840, 62594229, 62615741, 62630061, 62636814, 62645277, 62653052, 62659402, 62665815, 62667739, 62681734, 62681735 & 77002093. Product ID: 00771101020, Lot #: 61259321, 61622528, 61709486, 61784592, 61784593, 61784594, 61900027, 61966482, 61986040, 61998423, 62010415, 62071564, 62089271, 62118208, 62118210, 62145610, 62153681, 62243417, 62243418, 62253695, 62253698, 62265053, 62265055, 62282263, 62302393, 62309591, 62343088, 62350676, 62381050, 62400782, 62416737, 62423118, 62444860, 62445461, 62452781, 62478922, 62484355, 62489996, 62489997, 62515372, 62515373, 62547092, 62554235, 62564783, 62568626, 62594236, 62608688, 62615752, 62630069, 62630070 & 62630071. Product ID: 00771101100, Lot #: 61268897, 61397634, 61900032, 61945457, 61966419, 61992115, 62004546, 62014624, 62014628, 62053423, 62101433, 62114343, 62125039, 62125041, 62135146, 62179323, 62179326, 62198275, 62198276, 62201838, 62207928, 62213792, 62219957, 62246968, 62265060, 62275389, 62275393, 62282266, 62329285, 62329292, 62329294, 62350680, 62350682, 62361590, 62361594, 62370077, 62381077, 62381078, 62405441, 62411081, 62416741, 62416742, 62445470, 62450653, 62452787, 62457896, 62459027, 62466135, 62478022, 62489445, 62496194, 62515376, 62529440, 62540652, 62540653, 62560038, 62571850, 62571852, 62571855, 62578021, 62578023, 62608692, 62615756, 62615757, 62615760, 62622756, 62630077, 62636835, 62645298, 62645302, 62653074, 62653075, 62653076, 62659419, 62665830, 62667755, 62667758, 62667759 & 62681750. Product ID: 00771101120, Lot #: 61550131, 61574108, 61741520, 61812318, 61957205, 61986055, 61998379, 62042654, 62042655, 62089293, 62118226, 62118228, 62243431, 62243432, 62243433, 62246977, 62253712, 62271151, 62274971, 62289089, 62302421, 62302422, 62350689, 62367952, 62386127, 62386128, 62393357, 62393358, 62405456, 62449685, 62459038, 62466138, 62488383, 62496204, 62509307, 62540660, 62571873, 62571876, 62590744, 62622767, 62630086, 62630087, 62653088 & 62665848. Product ID: 00771101200, Lot #: 61239385, 61371703, 61729245, 61813502, 61837571, 61900043, 61925507, 61986064, 61992133, 62053440, 62096940, 62135171, 62153715, 62158688, 62163800, 62191554, 62226077, 62236570, 62238381, 62243440, 62246990, 62265069, 62275406, 62295570, 62316461, 62329304, 62329306, 62329308, 62361602, 62361603, 62361615, 62367955, 62381123, 62381127, 62386135, 62393365, 62393369, 62400796, 62433115, 62433118, 62445482, 62452797, 62459044, 62459405, 62484367, 62484368, 62484373, 62484605, 62484608, 62490022, 62496210, 62503259, 62515398, 62521974, 62540664, 62547111, 62554254, 62564803, 62571887, 62571888, 62571891, 62571892, 62571894, 62571895, 62578035, 62586925, 62594257, 62601289, 62601293, 62608711, 62622775, 62630096, 62645317, 62653098, 62659443, 62665854, 62667766, 62667767, 62667768, 62667770 & 62667773. Product ID: 00771101220, Lot #: 61684022, 61684027, 61792365, 61900048, 61951018, 62014651, 62014653, 62033982, 62033984, 62096947, 62096948, 62141489, 62179386, 62243451, 62243452, 62253735, 62274973, 62275409, 62275410, 62309633, 62335589, 62343112, 62343113, 62367968, 62370096, 62405483, 62411114, 62416762, 62445490, 62452805, 62472250, 62489469, 62490029, 62496221, 62521979, 62521982, 62554264, 62554266, 62560237, 62594272, 62594273, 62601298, 62601299, 62624984, 62653107 & 62665868. Product ID: 00771101300, Lot #: 60832119, 60837119, 61781476, 61910013, 61915163, 61945489, 62033922, 62033923, 62067065, 62085631, 62096953, 62101449, 62179397, 62184368, 62238385, 62243456, 62243458, 62275415, 62275417, 62289109, 62329318, 62329319, 62335595, 62342737, 62361622, 62367971, 62367972, 62370105, 62400816, 62405489, 62409718, 62411121, 62439010, 62439013, 62459056, 62466153, 62478037, 62478038, 62490033, 62496230, 62503267, 62540677, 62550210, 62554268, 62554269, 62554272, 62586943, 62586944, 62586950, 62594276, 62594278, 62608734, 62608736, 62615790, 62636872, 62636875, 62653117, 62653121, 62659457, 62659459, 62659460, 62665873, 62665879, 62667786, 62667788, 62681788 & 62681791.  Product ID: 00771101320, Lot #: 61271638, 61375629, 61626112, 61784607, 62010439, 62023916, 62163815, 62179415, 62184374, 62201868, 62226085, 62236571, 62243459, 62249191, 62275419, 62309647, 62316480, 62356539, 62381226, 62386154, 62416773, 62416774, 62427994, 62439017, 62472259, 62484382, 62484383, 62489479, 62489480, 62515430, 62540683, 62554275, 62564824, 62564825, 62564826, 62571923, 62594281, 62594282, 62594284, 62601314, 62615797, 62630117, 62653123 & 62659467.  Product ID: 00771101500, Lot #: 60663817, 61371715, 61631812, 61644835, 61825634, 61889909, 61910018, 61925521, 61998368, 62005258, 62067073, 62118255, 62153726, 62169808, 62169809, 62198304, 62231992, 62271178, 62271182, 62275422, 62302450, 62309652, 62329326, 62335599, 62335600, 62343123, 62350720, 62356545, 62367980, 62381243, 62393388, 62393390, 62405497, 62411150, 62416777, 62452825, 62457813, 62457946, 62472264, 62488409, 62488410, 62515434, 62515438, 62540687, 62578062, 62578063, 62586953, 62590762, 62601320, 62608741, 62622803, 62636881, 62653130, 62659472, 62665886 & 62667801.  Product ID: 00771101520, Lot #: 60697994, 60852321, 61067270, 61108714, 61468199, 61574112, 61576231, 61622536, 61791516, 61801913, 61894976, 61904711, 61986082, 61998444, 62022573, 62067528, 62071594, 62101463, 62114384, 62153728, 62226091, 62247023, 62271185, 62271186, 62282313, 62289115, 62295593, 62302455, 62350725, 62361630, 62367986, 62423163, 62459068, 62529451, 62540691, 62540692, 62540693, 62571929, 62571930, 62578065, 62586957, 62594293, 62630124, 62630125 & 62653134.  Product ID: 00771101600, Lot #: 61559496, 61559497, 61566491, 61595697, 61621514, 61679251, 61765957, 61860920, 61870584, 61951043, 61966461, 61972514, 62004576, 62023921, 62085098, 62089316, 62145634, 62165445, 62198310, 62219999, 62253761, 62253762, 62258730, 62295595, 62316483, 62329333, 62329334, 62335605, 62343130, 62361631, 62370117, 62383290, 62405503, 62416784, 62433153, 62439023, 62445507, 62489494, 62489495, 62496250, 62564837, 62586958, 62594294, 62594295, 62594296, 62601323, 62645341, 62665891 & 62667807.  Product ID: 00771101620, Lot #: 105548, 60384735, 61631832, 61673792, 61741538, 61765965, 61919554, 61963019, 61978880, 62010445, 62023923, 62085634, 62153731, 62163827, 62207976, 62247030, 62247031, 62253764, 62265084, 62295598, 62309659, 62329338, 62370120, 62393807, 62400823, 62428010, 62452833, 62521994, 62548508, 62564839, 62571934, 62578070, 62594298, 62601325, 62615807, 62622810, 62636887 & 61145719R.  Product ID: 00771101700, Lot #: 60400363, 60609658, 61440906, 61553101, 61553102, 61610075, 61610076, 61712743, 61825720, 61831226, 61870586, 61925530, 61941275, 61941277, 62010446, 62089319, 62130235, 62130237, 62145637, 62145640, 62201881, 62226094, 62253765, 62258732, 62265087, 62302461, 62312431, 62316485, 62329341, 62361633, 62433157, 62452834, 62452835, 62489497, 62564842, 62578071, 62601327, 62615809, 62622813, 62653143, 62653144, 62659485, 62665893 & 60460737R.  Product ID: 00771101720, Lot #: 60882289, 61171216, 61553140, 61553141, 61610031, 61690503, 61741528, 61805494, 61831190, 61978881, 61998451, 62004577, 62010447, 62078357, 62141505, 62179426, 62247035, 62253766, 62271191, 62302463, 62312432, 62323612, 62329344, 62343137, 62356553, 62367990, 62439025, 62445509, 62459413, 62489498, 62521997, 62540702, 62547135, 62564844, 62571936, 62578072, 62601328 & 62624988.  Product ID: 00771102000, Lot #: 60121420, 60369558, 60968999, 60993940, 61108748, 61559490, 61566487, 61930824, 61986087, 62179431, 62226096, 62329348, 62428017, 62466168, 62540703 & 62659489.  Product ID: 00771102020, Lot #: 60876607, 61054560, 61574113, 61791518, 61925533, 61963021, 61966522, 61978883, 62107738, 62184385, 62323616, 62329349, 62416791, 62554287 & 62615813.   Product ID: 00771102200, Lot #: 60180253, 60615468, 60852282, 60999884, 61085529, 61527309, 61527315, 61527321, 62243467, 62323618, 62329350, 62484390 & 62540705.  Product ID: 00771102220, Lot #: 102401, 60175884, 60199385, 60405478, 61098945, 61582026, 61963052, 62243470, 62323619, 62416792, 62586964, 60092140V, 60952630R & 61098945R.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, China, Europe, India, Japan, Korea and Singapore.
  • Descripción del producto
    Zimmer M/L Taper Hip Stem Standard & Extended Offset, HIP JOINT PROSTHESIS, Sizes: 5.0, 7.5, 9.0, 10.0, 11.0, 12.5, 13.5, 15.0, 11.25, 17.25, 20.0 & 22.5. The femoral stem component of a modular system that consists of an acetabular component, femoral head, femoral stem, and the instrumentation necessary for proper implantation of these components.
  • Manufacturer
    Zimmer, Inc.

Manufacturer

Zimmer, Inc.
  • Dirección del fabricante
    Zimmer, Inc., 1800 W Center St, Warsaw IN 46580-2304
  • Empresa matriz del fabricante (2017)
    Zimmer Biomet Holdings
  • Comentario del fabricante
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    USFDA